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Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.

by Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M
Ophthalmology.

Article Abstract:

OBJECTIVE: To report 2-year safety and efficacy outcomes from a trial of intravitreal triamcinolone acetonide (TA) injections (4 mg) in eyes with diabetic macular edema and impaired vision that persisted or recurred after laser treatment. DESIGN: Prospective, double-masked, placebo-controlled, randomized clinical trial. PARTICIPANTS AND CONTROLS: Sixty-nine eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment and 35 placebo. Two-year data were available for 60 of 69 (87%) eyes of 35 of 41 (85%) patients; 9 eyes of 6 patients were lost to follow-up, of which 6 received a placebo and 3 received intravitreal TA. INTERVENTION: Triamcinolone acetonide (0.1 ml) was injected through the pars plana using a 27-gauge needle. Eyes randomized to placebo received a subconjunctival injection of saline. MAIN OUTCOME MEASURES: Improvement of best-corrected logarithm of the minimum angle of resolution visual acuity (VA) by > or =5 letters after 2 years and incidence of moderate or severe adverse events. RESULTS: Improvement of > or =5 letters' best-corrected VA was found in 19 of 34 (56%) eyes treated with intravitreal TA, compared with 9 of 35 (26%) eyes treated with the placebo (z(generalized estimating equation) = 2.73, P = 0.006). The mean improvement in VA was 5.7 letters (95% confidence interval, 1.4-9.9) more in the intravitreal TA-treated eyes than in those treated with the placebo. An increase of intraocular pressure (IOP) of > or =5 mmHg was observed in 23 of 34 (68%) treated versus 3 of 30 (10%) untreated eyes (P<0.0001). Glaucoma medication was required in 15 of 34 (44%) treated versus 1 of 30 (3%) untreated eyes (P = 0.0002). Cataract surgery was performed in 15 of 28 (54%) treated versus 0 of 21 (0%) untreated eyes (P<0.0001). Two eyes in the intravitreal TA-treated group required trabeculectomy. There was one case of infectious endophthalmitis in the treatment group. CONCLUSION: Intravitreal TA improves vision and reduces macular thickness in eyes with refractory diabetic macular edema. This beneficial effect persists for up to 2 years with repeated treatment. Progression of cataract and elevation of IOP commonly occur but appear manageable. Spontaneous improvement over years can still occur in eyes that are apparently severely affected by diabetic macular edema.

intravitreal treatment for all?

By: seewell - Sat 9/09/2006 AM

This article is a classic example of how we can use a drug successfully to treat disease, but the adverse reactions make it a poor choice for many candidates. Those with refractory macular edema and 20/30 vision may not want to risk the glaucoma, aggressive cataract growth, and possible endophalmitis for a subtle improvement in their macular thickness that may not even be clinically appreciated. On the other hand those that suffer from debilitating macular edema refractory to first line focal laser treatment may want to risk these complications for a chance at improved edema. I find it interesting that the placebo used here was a subconjunctival injection of saline - why not use an subconjunctival or subtenons injection of triamcinoloe as the "placebo?" - is it possible that there would not have been a statistically significant difference in the reduction of macular thickness on OCT? There was a study published in 2005 which showed no improvement in macular edema with subtenons injection of triamcinolone vs placebo after 4 months on 60 eyes. Maybe if we followed those patients for 4 years we would find different results...and what about their rates of glaucoma, cataract, and endophthalmitis after 4 years?? It is important to remember that foremost as physicians we do not want to do harm on our patients. I wonder if we are forgetting about the big risk that we subject our patients to as we have discovered a new love of injecting medications into the vitreous.

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